ESR1 Mutated Metastatic Breast Cancer Market to Expand Significantly by 2034, States DelveInsight Report | Sanofi, Sun Pharma, Zenopharm, Arvinas, Sermonix Pharma, H3 Biomedicine, Radius Pharma

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ESR1 Mutated Metastatic Breast Cancer Market to Expand Significantly by 2034, States DelveInsight Report | Sanofi, Sun Pharma, Zenopharm, Arvinas, Sermonix Pharma, H3 Biomedicine, Radius Pharma
The Key ESR1 Mutated Metastatic Breast Cancer Companies in the market include – AstraZeneca, Sermonix Pharmaceuticals, Sun Pharma Advanced Research Company, Radius Pharmaceuticals/ Menarini Group, Pfizer, G1 Therapeutics, Sanofi, Sun PharmaAdvanced Research Company, Zenopharm, Arvinas, Sermonix Pharmaceuticals, H3 Biomedicine/ Eisai, Roche, and others

 

DelveInsight’s “ESR1 Mutated Metastatic Breast Cancer Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the ESR1 Mutated Metastatic Breast Cancer, historical and forecasted epidemiology as well as the ESR1 Mutated Metastatic Breast Cancer market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

 

To Know in detail about the ESR1 Mutated Metastatic Breast Cancer market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; ESR1 Mutated Metastatic Breast Cancer Market Forecast

 

Some of the key facts of the ESR1 Mutated Metastatic Breast Cancer Market Report:

  • The ESR1 Mutated Metastatic Breast Cancer market size was valued ~USD 1,300 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)

  • In May 2025, Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) have shared comprehensive findings from the Phase 3 VERITAC-2 clinical trial (NCT05654623), which assessed vepdegestrant as a monotherapy against fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC). The study focused on patients whose disease had progressed following prior treatment with CDK4/6 inhibitors and endocrine therapy. These results were featured during the American Society of Clinical Oncology (ASCO®) press briefing and recognized in the Best of ASCO selections.

  • In April 2025, AstraZeneca recently reported promising interim topline results from the SERENA-6 Phase III trial, a randomized, multicenter, double-blind study. The trial assessed the efficacy of camizestrant, an investigational next-generation oral selective estrogen receptor degrader (SERD), when used in combination with one of three CDK4/6 inhibitors—Pfizer’s Ibrance, Eli Lilly’s Verzenio, or Novartis’ Kisqali—compared to the standard aromatase inhibitor plus CDK4/6 inhibitor regimen. This first-line treatment approach targeted patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer carrying a detectable estrogen receptor alpha (ESR1) mutation.

  • In April 2025, Breast cancer research is advancing swiftly, with ongoing clinical trials and innovative therapies bringing renewed optimism for patients. Notable developments include recent results from the EMBER-3 trial (NCT04975308), the growing prominence of antibody-drug conjugates (ADCs), and the promising outlook for emerging treatment options.

  • In March 2025, Results from the Phase III VERITAC-2 trial (NCT05654623) showed that vepdegestrant (ARV-471) as a monotherapy significantly improved progression-free survival (PFS) compared to fulvestrant in patients with estrogen receptor 1-mutant (ESR1m) advanced or metastatic breast cancer. However, the treatment did not meet the threshold for statistical significance in the overall intent-to-treat (ITT) population.

  • In 2023, the United States held the largest market share for ESR1-mutated Metastatic Breast Cancer among the 7MM, with an estimated value of around USD 820 million, and this figure is projected to grow by 2034.

  • In 2023, the combination of aromatase inhibitor and CDK4/6 inhibitor is anticipated to generate the highest revenue in the first-line treatment setting in the United States, reaching around USD 500 million.

  • In 2023, the United States reported approximately 18,800 diagnosed prevalent cases of ESR1-mutated Metastatic Breast Cancer.

  • In 2023, the estimated number of diagnosed prevalent cases of ESR1-mutated HR+ Metastatic Breast Cancer receiving first-line treatment in the United States was approximately 18,400.

  • DelveInsight estimates that Japan accounted for nearly 45,000 cases of metastatic breast cancer in 2023, representing about 13% of the total cases across the 7MM.

  • Future treatments (First-line) like Giredestrant + Palbociclib, Amcenestrant + Palbociclib, and Camizestrant (AZD9833) + Palbociclib have the potential to significantly alter the ESR1 Mutated Metastatic Breast Cancer market

  • Key ESR1 Mutated Metastatic Breast Cancer Companies: AstraZeneca, Sermonix Pharmaceuticals, Sun Pharma Advanced Research Company, Radius Pharmaceuticals/ Menarini Group, Pfizer, G1 Therapeutics, Sanofi, Sun PharmaAdvanced Research Company, Zenopharm, Arvinas, Sermonix Pharmaceuticals, H3 Biomedicine/ Eisai, Roche, and others

  • Key ESR1 Mutated Metastatic Breast Cancer Therapies: Camizestrant (AZD9833), Lasofoxifene, SCO-120, Elacestrant (RAD1901), Ibrance (Palbociclib), Amcenestrant, Rintodestrant (G1T48), G1 Therapeutics, ZB716, ARV-471, Lasofoxifene, H3B-6545, Giredestrant(RG6171, GDC9545), and others

  • The ESR1 Mutated Metastatic Breast Cancer epidemiology based on Treatment Line-specific Cases analyzed that in 2021 out of the total diagnosed prevalent cases of ESR1 Mutated Metastatic Breast Cancer, in the United States, 72% were from the first-line

  • The ESR1 Mutated Metastatic Breast Cancer market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage ESR1 Mutated Metastatic Breast Cancer pipeline products will significantly revolutionize the ESR1 Mutated Metastatic Breast Cancer market dynamics.

 

ESR1 Mutated Metastatic Breast Cancer Overview

ESR1 mutated metastatic breast cancer refers to a subtype of breast cancer where mutations occur in the estrogen receptor 1 (ESR1) gene. The ESR1 gene encodes the estrogen receptor alpha, a protein that plays a critical role in breast cancer growth and progression by responding to estrogen signals. Mutations in the ESR1 gene can lead to changes in the estrogen receptor protein, rendering it more active and resistant to hormonal therapies like tamoxifen or aromatase inhibitors.

 

Get a Free sample for the ESR1 Mutated Metastatic Breast Cancer Market Report:

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ESR1 Mutated Metastatic Breast Cancer Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

 

ESR1 Mutated Metastatic Breast Cancer Epidemiology Segmentation:

The ESR1 Mutated Metastatic Breast Cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

  • Total Prevalence of ESR1 Mutated Metastatic Breast Cancer

  • Prevalent Cases of ESR1 Mutated Metastatic Breast Cancer by severity

  • Gender-specific Prevalence of ESR1 Mutated Metastatic Breast Cancer

  • Diagnosed Cases of Episodic and Chronic ESR1 Mutated Metastatic Breast Cancer

 

Download the report to understand which factors are driving ESR1 Mutated Metastatic Breast Cancer epidemiology trends @ ESR1 Mutated Metastatic Breast Cancer Epidemiology Forecast

 

ESR1 Mutated Metastatic Breast Cancer Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the ESR1 Mutated Metastatic Breast Cancer market or expected to get launched during the study period. The analysis covers ESR1 Mutated Metastatic Breast Cancer market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the ESR1 Mutated Metastatic Breast Cancer Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

 

ESR1 Mutated Metastatic Breast Cancer Therapies and Key Companies

  • ORSERDU (elacestrant): Stemline Therapeutics (a wholly owned subsidiary of the Menarini Group)

  • Camizestrant (AZD9833): AstraZeneca

  • Lasofoxifene: Sermonix Pharmaceuticals

  • Elacestrant (RAD1901): Radius Pharmaceuticals/ Menarini Group

  • Ibrance (Palbociclib): Pfizer

  • Amcenestrant: Sanofi

  • Rintodestrant (G1T48): G1 Therapeutics

  • G1 Therapeutics: Sun PharmaAdvanced Research Company

  • ZB716: Zenopharm

  • ARV-471: Arvinas

  • Lasofoxifene: SermonixPharmaceuticals

  • H3B-6545: H3 Biomedicine/ Eisai

  • Giredestrant(RG6171, GDC9545): Roche

 

Discover more about therapies set to grab major ESR1 Mutated Metastatic Breast Cancer market share @ ESR1 Mutated Metastatic Breast Cancer Treatment Market

 

ESR1 Mutated Metastatic Breast Cancer Market Strengths

  • ORSERDU is the first endocrine innovation in 20 years specifically targeting ESR1 mutations in ER+, HER2−, advanced, or metastatic breast cancer patients with disease progression following at least one line of endocrine therapy.

  • ESR1 mutations are common in breast cancer, and research focuses on understanding their mechanisms and developing targeted therapies.

  • Combination therapies have shown promise in treatingESR1-mutant breast cancer, which could improve outcomes for patients

 

ESR1 Mutated Metastatic Breast Cancer Market Opportunities

  • There is a need for new ET agents with strong and durable activity in heavily treated patients, including after standard-of-care first-line therapy with CDK4/6 inhibitors and in those withESR1mutations

  • Advances in genomics and precision medicine could lead to more personalized treatment options for patients withESR1mutations

  • Clinical trials investigating new therapies or combinations of therapies could improve patient outcomes

  • An improved understanding of the mechanisms behindESR1mutationscould lead to the development of more effective targeted therapies

 

Scope of the ESR1 Mutated Metastatic Breast Cancer Market Report

  • Study Period: 2020–2034

  • Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

  • Key ESR1 Mutated Metastatic Breast Cancer Companies: AstraZeneca, Sermonix Pharmaceuticals, Sun Pharma Advanced Research Company, Radius Pharmaceuticals/ Menarini Group, Pfizer, G1 Therapeutics, Sanofi, Sun PharmaAdvanced Research Company, Zenopharm, Arvinas, Sermonix Pharmaceuticals, H3 Biomedicine/ Eisai, Roche, and others

  • Key ESR1 Mutated Metastatic Breast Cancer Therapies: Camizestrant (AZD9833), Lasofoxifene, SCO-120, Elacestrant (RAD1901), Ibrance (Palbociclib), Amcenestrant, Rintodestrant (G1T48), G1 Therapeutics, ZB716, ARV-471, Lasofoxifene, H3B-6545, Giredestrant(RG6171, GDC9545), and others

  • ESR1 Mutated Metastatic Breast Cancer Therapeutic Assessment: ESR1 Mutated Metastatic Breast Cancer current marketed and ESR1 Mutated Metastatic Breast Cancer emerging therapies

  • ESR1 Mutated Metastatic Breast Cancer Market Dynamics: ESR1 Mutated Metastatic Breast Cancer market drivers and ESR1 Mutated Metastatic Breast Cancer market barriers

  • Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

  • ESR1 Mutated Metastatic Breast Cancer Unmet Needs, KOL’s views, Analyst’s views, ESR1 Mutated Metastatic Breast Cancer Market Access and Reimbursement

 

To know more about ESR1 Mutated Metastatic Breast Cancer companies working in the treatment market, visit @ ESR1 Mutated Metastatic Breast Cancer Clinical Trials and Therapeutic Assessment

 

Table of Contents

1. ESR1 Mutated Metastatic Breast Cancer Market Report Introduction

2. Executive Summary for ESR1 Mutated Metastatic Breast Cancer

3. SWOT analysis of ESR1 Mutated Metastatic Breast Cancer

4. ESR1 Mutated Metastatic Breast Cancer Patient Share (%) Overview at a Glance

5. ESR1 Mutated Metastatic Breast Cancer Market Overview at a Glance

6. ESR1 Mutated Metastatic Breast Cancer Disease Background and Overview

7. ESR1 Mutated Metastatic Breast Cancer Epidemiology and Patient Population

8. Country-Specific Patient Population of ESR1 Mutated Metastatic Breast Cancer

9. ESR1 Mutated Metastatic Breast Cancer Current Treatment and Medical Practices

10. ESR1 Mutated Metastatic Breast Cancer Unmet Needs

11. ESR1 Mutated Metastatic Breast Cancer Emerging Therapies

12. ESR1 Mutated Metastatic Breast Cancer Market Outlook

13. Country-Wise ESR1 Mutated Metastatic Breast Cancer Market Analysis (2020–2034)

14. ESR1 Mutated Metastatic Breast Cancer Market Access and Reimbursement of Therapies

15. ESR1 Mutated Metastatic Breast Cancer Market Drivers

16. ESR1 Mutated Metastatic Breast Cancer Market Barriers

17. ESR1 Mutated Metastatic Breast Cancer Appendix

18. ESR1 Mutated Metastatic Breast Cancer Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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